Clinical development of Rimonabant

At Sinfatin we are proud to announce that the European Commission, by means of Implementing Decision C(2026) 7475, of 19 October 2026, has designated rimonabant, the active ingredient in SFT-1, as an orphan drug for the treatment of spinal cord injuries (Community register of orphan medicinal products EU/3/26/3289). The Decision is based on the positive opinion issued on 10 September 2026 by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), in accordance with the criteria laid down in Article 3(1) of Regulation (EC) No 141/2000 on orphan medicinal products.

Spinal cord injury is a highly complex and rare neurological condition in the European Union, profoundly affecting the quality of life and social participation of both those affected and their caregivers. Our clinical program focuses on improving the walking ability of individuals with spinal cord injury who retain the capacity to walk.

SFT-1 contains a low dose (5 mg) of rimonabant as its active ingredient. Rimonabant is an inverse agonist/antagonist of CB1 cannabinoid receptors, capable of crossing the blood-brain barrier and acting within the central nervous system (CNS). By blocking the constitutive activity of the CB1 receptor, rimonabant promotes the release of excitatory neurotransmitters and increases the excitability of motor neurons, both cortically and spinally. We expect that this effect may help compensate for the decreased excitability of neurons below the level of spinal cord injury, thereby promoting the activation of a greater number of motor neurons and, consequently, muscle fibers.

The results available to date, including those from the phase 2b clinical trial, RIMOFATSCI-2, indicate that SFT-1 has the potential to improve motor function in people with incomplete thoracolumbar spinal cord injury, meeting a previously unmet therapeutic need.

This designation provides a significant boost to the continued development of SFT-1 for this indication. It grants us access to EMA protocol assistance (specific scientific and regulatory advice for orphan drugs) and allows us, as an SME, to benefit from fee exemption when submitting the marketing authorization application. Once authorized, SFT-1 will be eligible for a period of market exclusivity in the European Union (currently 10 years).

We want to share this achievement with the clinical centers that have accompanied us on this journey, especially with the National Hospital for Paraplegics of Toledo and its Foundation, where this project took its first steps, and with the Guttmann Institute of Barcelona.

We also extend our gratitude and congratulations to the technology centers, organizations, and companies with whom we have worked and continue to collaborate in the development of SFT-1: BIC Gipuzkoa, where our development laboratory is located; Medalchemy, collaborators in the synthesis of the active ingredient; Tecnalia, in the development and analytical validation; Laboratorium Sanitatis, in the manufacture of development batches and the medication for clinical trials; CIDETEC, in the characterization of new formulations; and the Teófilo Hernando Foundation in conducting clinical trials. And to our partners, especially SAMOS Medical Enterprise and Pharmaceutical Innovation Services, for their support and contribution to the product's development.

At Sinfatin we continue working to achieve our goal: to obtain marketing authorization for SFT-1 and expand its development to other indications.